Agomab Therapeutics has announced the design of its phase 2b NOV‑ERA study of ontunisertib in fibrostenosing Crohn’s disease, following alignment with the US Food and Drug Administration on key elements of the trial. The company expects to begin dosing participants in the second half of 2026.
Agomab said the study will evaluate its oral, GI‑restricted ALK5 inhibitor in a condition that affects around 46% of Crohn’s disease patients and for which no approved pharmacological therapies exist.
Fibrotic strictures in the intestinal tract can cause obstructive symptoms that lead to dietary change, malnutrition and surgery.
The company has agreed the study’s primary efficacy endpoint with the FDA, focusing on endoscopic passability at Week 24 as assessed by the SES‑CD narrowing score. The protocol has been submitted to the FDA, cleared central IRB approval in the US and received approval from Health Canada. Clinical Trial Applications have also been filed in multiple territories, including the EU and Asia Pacific.
Philippe Wiesel, Chief Medical Officer of Agomab, said: “The NOV‑ERA study breaks new ground as the first Phase 2b study in FSCD, an area of high unmet medical need, and will inform dose selection and pivotal endpoints.”
He explained: “The submission of the study protocol to key regulatory agencies is a crucial milestone in the late‑stage development of ontunisertib in FSCD. We are now focused on completing operational preparations and look forward to initiating patient enrollment in the coming months.”
The randomized, double‑blind, placebo‑controlled, dose‑ranging phase 2b trial will enrol up to 320 adults with symptomatic FSCD. Participants must have at least one naive or anastomotic endoscopically non‑passable ileal stricture confirmed by centrally read SES‑CD.
Patients will be randomised 1:1:1:1 to receive one of three ontunisertib doses or placebo twice daily over a 52‑week treatment period, following a 6‑week screening phase.
The primary endpoint is the proportion of patients achieving endoscopic passability at Week 24, with secondary endpoints including MRE changes, SES‑CD changes, endoscopic response and remission, patient‑reported outcomes and time to FSCD‑related events.
Ontunisertib remains investigational and is not approved by any regulatory authority.
